There has been a notable uptick in Warning Letters being issued to universities from the Food & Drug Administration (FDA). An example of this trend occurred when analyses was performed using Western Blot Analysis (WBA) to evaluate clinical trial participants' blood and cerebrospinal fluid (CSF).  However, WBA can only determine relative protein abundance and not absolute protein concentration and is not as rigidly controlled via software controls as other more widely used bioanalytical techniques such as ELISA or mass spectrometry. The FDA conducted a routine study­ specific investigation of the laboratory and it was concluded that there were no documented laboratory procedures to support the study results. Furthermore, the equipment used in the evaluation of the trial samples were not maintained, standardized, or calibrated. The conduct of the overall laboratory and reporting of study results caused this phase of the study to essentially be invalidated by the FDA. Because of the lack of study controls, the university, the Principal Investigator and the Sponsor's reputations were irrevocably damaged. In fact, this lack of regulation caused a significant loss in the Sponsor's stock valuation after the FDA issued their findings. It is important to understand how subpar and/or lacking process controls can affect the overall integrity of your study.

This presentation aims to showcase how sound scientific and regulatory practices go hand-in-hand, ultimately helping you and your organization avoid the pitfalls that impacted this clinical trial.

Jera Kantz, MBA, LATG, RQAP-GLP

With over 16 years in the CRO industry, Jera A. Kantz, MBA, LATg, RQAP-GLP, serves as the Quality Assurance Manager at Alturas Analytics, Inc. Jera’s early history as a Research Associate II (RAII) with a focus on experimental therapeutics provided the background and a passion for the preclinical drug research process. After obtaining her AALAS LATG certification she then transitioned to Quality Assurance Auditor at MPI Research.

In 2013, Jera joined the Charles River Laboratories QAU and quickly advanced to Senior Quality Systems Auditor. She hosted numerous client audits and became proficient at auditing computer systems validations and bioanalysis across immunogenicity, cell culture, flow cytometry and PCR techniques. An important aspect of Jera’s position is training auditors and general site staff in GLP, GCP, and Part 11 compliance, OECD principles and other applicable Guidance for Industry. Influencing others to embrace compliance that intuitively leads to generation of quality data and patient safety is her ultimate goal.

Jera is an active member and contributor to the Society of Quality Assurance.